MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3853

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

It was reported that a labeling issue occurred.While outside the patient, during preparation of a percutaneous transluminal coronary angioplasty (ptca), a 3.00mm x 6mm wolverine coronary cutting balloon was selected for treatment, but the balloon inner plastic packaging was noticed to be mislabeled.It was noted that a 3.00mm x 6mm wolverine balloon appeared on the box, but the inside plastic packaging was noticed to be a 2.75mm x 6mm wolverine balloon.No damage to the package was noted.The procedure was completed with another device.No patient complications were reported in relation to this event.

Manufacturer Narrative

Device evaluated by manufacturer: received for analysis was an open shelf carton labelled for a wolverine cb mr, us 3.00mm x 6mm; batch # 28156142 upn: h74939401063000 use by: 2023 - 09 - 2.The closure strip was torn open which indicates that the box carton had been opened.No damage was observed with the shelf carton.Inside the carton was a sealed tyvek pouch which was labelled for a wolverine 2.75 x 6mm; lot # 27921814-100; batch # 28023060 upn: h74939401062750 use by : 2023 - 09 - 15.No issues noted with the pouch (no tears, punctures or holes in the material).The wolverine catheter was in its protective hoop within the pouch.

Event Description

It was reported that a labeling issue occurred.While outside the patient, during preparation of a a percutaneous transluminal coronary angioplasty (ptca), a 3.00mm x 6mm wolverine coronary cutting balloon was selected for treatment, but the balloon inner plastic packaging was noticed to be mislabeled.It was noted that a 3.00mm x 6mm wolverine balloon appeared on the box, but the inside plastic packaging was noticed to be a 2.75mm x 6mm wolverine balloon.No damage to the package was noted.The procedure was completed with another device.No patient complications were reported in relation to this event.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13840279
• MDR Text Key: 287581852
• Report Number: 2134265-2022-02998
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888178
• UDI-Public: 08714729888178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0028056142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1